Responsibilities:
- Manage projects for laboratory instrumentation (installation, calibration, qualification, decommission, instrument moves), Data Integrity (DI), computerized instrument support, Controlled Storage (chamber profiling, alarm monitoring), and ancillary lab systems (water, monitoring systems, utilities).
- Author, review, and/or contribute to quality documentation (experimental protocols, results summaries, SOPs, and software configuration documents).
- Coordinate with internal/external partners (laboratory personnel, QA, CS, VRB, IT/BTS, contractors, vendors) to align scope, timelines, and deliverables.
- Manage and multitask instrument activities to support pipeline; deliver critical lab priorities on time and escalate concerns.
- Maintain knowledge of instrument processes and drive process improvement.
- Support audits related to instrumentation and data integrity, including follow-on activities.
- Maintain activities supported by ARD LC IMT (OOT, instrument inventory, instrument scheduler, red stickers).
- Support other cGMP quality activities as needed.
- May lead/develop/coach temporary workers and summer interns.
- Drive/coordinate operational decision-making site basis; adapt to changing environments and balance priorities.
- Provide guidance on regulatory/cGMP expectations for novel analytical instrumentation.
- Build cross-departmental operational strategies; influence long-range strategies.
- Create a learning environment; handle uncertainty/ambiguity/risk in alignment with corporate/regulatory policies.
- Raise the bar for efficient/reliable execution; learn fast and adjust quickly.
Qualifications:
- Bachelorโs degree or equivalent + typically 5 years of experience; or Masterโs degree or equivalent + typically 2 years of experience.
- Demonstrated theoretical and practical knowledge/experience in analytical development, including international pharmaceutical regulations and cGMPs.